WE-TRUST (Workflow Optimization to Reduce Time to Endovascular Reperfusion for Ultra-fast Stroke Treatment)
NCT ID: NCT04701684
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
594 participants
INTERVENTIONAL
2021-06-23
2027-04-01
Brief Summary
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Detailed Description
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In the DTAS workflow stroke patients are diagnosed and treated in the interventional suite without interruption. The Cone-Beam CT (CBCT) capabilities of the interventional X-ray system are utilized to perform triage, directly followed by stroke treatment.
The primary objective of the WE-TRUST study is to demonstrate that the DTAS triage workflow involving CBCT results in superior patient outcome in ischemic stroke patients with confirmed Large Vessel Occlusion as compared to the conventional CT/MR triage workflow.
The WE-TRUST study will be running in 16+ sites to enroll 500+ patients globally.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Conventional CT/MR triage workflow
Conventional CT/MR triage
First a CT or MRI exam is acquired for triage. In case of an ischemic stroke the patient is then treated in an interventional suite.
Direct tot Angiography Suite (DTAS) triage workflow
Direct to Angio Suite (DTAS) Philips' CBCT triage
Stroke patients are diagnosed and treated (mechanical thrombectomy) in the same angio suite
Interventions
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Direct to Angio Suite (DTAS) Philips' CBCT triage
Stroke patients are diagnosed and treated (mechanical thrombectomy) in the same angio suite
Conventional CT/MR triage
First a CT or MRI exam is acquired for triage. In case of an ischemic stroke the patient is then treated in an interventional suite.
Eligibility Criteria
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Inclusion Criteria
* Baseline NIHSS score obtained prior to randomization must be equal or higher than 10 points.
* Subjects with no significant pre-stroke functional disability (modified Rankin scale 0 - 2).
* Subjects suspected of acute ischemic stroke with an estimated arrival time at a stroke center (clinical investigational site participating in this study) \< 6 hours from symptom onset OR wake-up stroke with time last known well of \< 12 hours and symptoms discovered within 6 hours from arrival time at a stroke center. Symptom onset is defined as point in time the patient was last known well (at baseline).
* Informed consent obtained from patient or his or her legally designated representative (if locally required).
* Angiography suite immediately available.
* Endovascular treatment team immediately available (Neurologist, Neurointerventionalist, Anesthesiologist, Nursing, Technicians as per local standard practice)
Exclusion Criteria
* Known baseline platelet count \< 30.000/μL
* Baseline blood glucose of \< 50mg/dL (\< 2.78mmol/l)
* For patients receiving thrombolysis: severe, sustained hypertension (SBP \> 185 mm Hg or DBP \> 110 mm Hg). Note: If the blood pressure can be successfully reduced and maintained at the acceptable level using AHA/ASA guidelines recommended medication (including IV antihypertensive drips), the patient can be enrolled.
* Patients from a transfer center (Primary Stroke Center) with a CT/MR that is not required to be redone in the Comprehensive Stroke Center as per discretion of the physician or per local standards (e.g. CT/MR less than 90 minutes old).
* Patients in coma (NIHSS item of consciousness \>1) defined as totally unresponsive; responding only with reflexes or being areflexic (Intubated patients for transfer could be randomized only in case an NIHSS is obtained by a neurologist prior transportation).
* Patients with extreme vomiting
* Patients that are extremely agitated
* Seizures at stroke onset which would preclude obtaining a baseline NIHSS
* Serious, advanced, or terminal illness with anticipated life expectancy of less than one year.
* Patients acquired stroke while in-hospital
* History of life-threatening allergy (more than rash) to contrast medium
* Cerebral vasculitis
* Patients with a pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations, mRS score at baseline must be ≤2. This excludes patients who are severely demented, require constant assistance in a nursing home type setting or who live at home but are not fully independent in activities of daily living (toileting, dressing, eating, cooking and preparing meals, etc.)
* Unlikely to be available for 90-day follow-up (e.g. no fixed home address, visitor from overseas).
* Patients with unstable clinical status who require emergent life support care
* Any condition that, in the judgment of the investigator could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study.
* Subject participates in a potentially confounding drug or device trial during the course of the study.
* Woman of childbearing potential who is known to be pregnant on admission.
* Subject is Philips employee or their family members residing with this Philips employee.
18 Years
ALL
No
Sponsors
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Philips Clinical & Medical Affairs Global
INDUSTRY
Responsible Party
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Principal Investigators
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Raul G Nogueira
Role: PRINCIPAL_INVESTIGATOR
UPMC Stroke Institute, Pittsburgh
Marc Ribo
Role: PRINCIPAL_INVESTIGATOR
Vall d'Hebron University Hospital, Barcelona
Locations
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Baptist Medical Center
Jacksonville, Florida, United States
Grady Memorial Hospital/Emory University
Atlanta, Georgia, United States
Montefiore Medical Center
The Bronx, New York, United States
La Sagrada Familia Clinic
José Hernández, , Argentina
Hospital Geral de Fortaleza
Fortaleza, , Brazil
Hospital de Base
São José do Rio Preto, , Brazil
Hospital Estadual Central - Fundação Estadual de Inovação em Saúde - Inova Capixaba
Vitória, , Brazil
Hospices Civils de Lyon
Lyon, , France
CHU Montpellier
Montpellier, , France
Bicêtre Hospital
Paris, , France
University Hospital Bonn (UKB Universitätsklinikum Bonn)
Bonn, , Germany
Klinikum Kassel
Kassel, , Germany
Universitätsklinikum Schleswig-Holstein Lübeck
Lübeck, , Germany
Klinikum rechts der Isar der TU München
Munich, , Germany
St. Antonius Ziekenhuis
Nieuwegein, , Netherlands
Haaglanden Medical Center
The Hague, , Netherlands
University Emergency Hospital Bucharest
Bucharest, , Romania
Hospital Clinico San Carlos
Madrid, Moncloa - Aravaca, Spain
Vall d'Hebron University Hospital
Barcelona, , Spain
Hospital Universitari Doctor Josep Trueta de Girona
Girona, , Spain
Hospital Virgen del Rocio
Seville, , Spain
İstanbul Aydin University medical park florya hospital
Istanbul, , Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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Ricardo Hanel
Role: primary
Diogo Haussen
Role: primary
Raul Nogueira
Role: backup
Lee
Role: primary
Pedro Lylyk
Role: primary
Francisco Mont' Alverne
Role: primary
Fabricio Oliveira Lima
Role: backup
Raquel Hidalgo
Role: primary
Derval Pimentel
Role: primary
Leandro De Assis Barbosa
Role: backup
Costalat
Role: primary
Arquizan
Role: backup
Laurent Spelle
Role: primary
Felix Bode
Role: primary
Roth
Role: primary
Siekmann
Role: backup
Schramm
Role: primary
Royl
Role: backup
Tobias Boeckh-Behrens
Role: primary
Radu
Role: primary
Tiu
Role: backup
Gomez Escalonilla
Role: primary
Moreu
Role: backup
Marc Ribo
Role: primary
Terceño
Role: primary
Silva
Role: backup
Alejandro Gonzalez
Role: primary
Francisco Moniche
Role: backup
Related Links
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WE-TRUST study information website
Other Identifiers
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XCY607-130512
Identifier Type: -
Identifier Source: org_study_id